NCT04231409终止不适用
Study to Demonstrate the Value of Fast-Acting Subperception (FAST) Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain (COMBO Study)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Overall Pain Responder Rate
研究概览
简要总结
Study to Demonstrate the Value of Fast-Acting Subperception (FAST) using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
- •22 years of age or older at time of enrollment
- •Able to independently read and complete all questionnaires and assessments provided in English
- •Signed a valid, IRB-approved informed consent form (ICF) provided in English
排除标准
- •Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
- •Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- •Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
- •Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
研究组 & 干预措施
WaveWriter Settings
Active Comparator
WaveWriter Programming
干预措施: Boston Scientific Spectra WaveWriter SCS System (Device)
Conventional Settings
Active Comparator
Conventional Programming
干预措施: Boston Scientific Spectra WaveWriter SCS System (Device)
结局指标
主要结局
Overall Pain Responder Rate
时间窗: 3 months post-randomization
Proportion of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization
次要结局
未报告次要终点
研究者
研究点 (6)
Loading locations...
相似试验
招募中
不适用
Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE TrialOut-Of-Hospital Cardiac ArrestNCT06564675University of Helsinki300
已完成
不适用
Role of Slow-wave Activity and Plasticity in MDDDepressionNCT04150718University of Pennsylvania77
已完成
不适用
An Evaluation of Actigraphy as an Indicator of Sleep and Wake in ChildrenSleep MonitoringNCT00928993Oregon Health and Science University48
招募中
不适用
Investigating Surprise Signals in the Anterior InsulaHealthyDrug Resistant EpilepsyNCT05997758University Hospital, Geneva50
已完成
不适用
Sleep Modulation as Antidepressant Randomized TrialHealthyDepressionNCT05685771Giulia Da Poian70